Surgical drape with adhesive attachment means

ABSTRACT

A disposable surgical drape sheet, of the type having a nonwoven sheet for placing over a surgical patient and having a reinforced fenestration area with a fenestration to expose an operative area, is provided with a pair of elongated strips of normally tacky and pressure-sensitive adhesive along one pair of opposed edges of the fenestration. A pair of removable peel strips covering the adhesive strips are removed before using the sheet, thereby exposing the adhesive and permitting the sheet to be secured to the patient.

United States Patent Schrading et a1.

[54] SURGICAL DRAPE WITH ADHESIVE ATTACHMENT MEANS [72] Inventors: MarkS. Schrading, Menosha; Terry L.

Winters, Neenah, both of Wis.

[73] Assignee: Kimberly-Clark Corporation, Neenah,

Wis.

[22] Filed: July27,l970

[21] App1.No.: 58,336

[52] U.S. Cl. ..128/132 D [51] Int. Cl. ..A6li 13/00 [58] Field oiSearch..128/132 D, 155-157, 128/296 [56] References Cited UNITED STATESPATENTS 3,561,440 2/1971 Bayer ....l28/132 D 3,503,391 3/1970 Melges.......l28/l32 D 3,561,439 2/1971 Bayer ..128/132 D [151 3,669,106 51 June13, 1972 3,484,330 12/1969 Sokolowski et al. ..128/132 D 3,263,6808/1966 Morgan ..128/132 D FOREIGN PATENTS 0R APPLICATIONS 668,402 8/1963Canada 128/132 D 944,329 12/1963 Great Britain ..128/132 D PrimaryExaminer-Richard A. Gaudet Assistant Examiner-.I. B. MitchellAnorney-Wolfe, Hubbard, Leydig, Voit & Osann. Ltd.

[57] ABSTRACT A disposable surgical drape sheet, of the type having anonwoven sheet for placing over a surgical patient and having areinforced fenestration area with a fenestration to expose an operativearea, is provided with a pair of elongated strips of normally tacky andpressure-sensitive adhesive along one pair of opposed edges of thefenestration. A pair of removable peel strips covering the adhesivestrips are removed before using the sheet, thereby exposing the adhesiveand permitting the sheet to be secured to the patient.

6 Clains, 4 Drawing figures PATENTEDJum I972 3.669.106

WI) 4. IV/J ZZWJ SURGICAL DRAPE WITH ADHESIVE ATTACHMENT MEANS Thisinvention relates generally to surgical drape sheets, and moreparticularly, to an improved disposable surgical drape having improvedmeans for attaching the drape to a surgical patient.

Customarily, a patient who is to undergo surgery or the like is partlycovered with a drape sheet having a generally central fenestration whichexposes only the operative area. The previous use of cloth drapes forthis purpose, with their attendant initial and laundry costs and theirdifficulty in sterilization, has now largely given way to the use ofdisposable drapes.

At present, disposable drapes are of two general types, namely those ofa paper-like nonwoven fabric and those made of a plastic material. Whileboth are used, they each have well recognized limitations. Nonwovendisposables, for example, tend to be somewhat more slippery than textilefabrics, and the use of skin clips or the like to secure the drape tothe patient is inconvenient for the surgical team and perhaps painfulfor the patient. Plastic sheets generally tend to be even more slippery.

It has been proposed to overcome the disadvantages of disposablesurgical drapes by utilizing adhesives to secure the drape in position.However, adhesive brushed or sprayed onto the patient is inconvenient atbest, while adhesives applied to the drape have tended to hindermanipulation of the drape, particularly relocation of the drape after itis placed on the patient, which may be necessary if the drape isinitially positioned incorrectly.

It is the primary object of the present invention to provide an improveddisposable surgical drape that is securable to the patient without theneed for skin clips or the like, yet can be readily relocated ifnecessary after the initial securement of the drape on the patient.

A more detailed object of the invention is to provide a disposablesurgical drape having a reinforced fenestration area with afenestration, which is adhesively secured to the patient both to preventSlipping and to hold the drape flat to prevent instruments, fluids andthe like from inadvertently getting under the drape through thefenestration.

Other and further aims, objects, and advantages of the invention willbecome apparent as the description proceeds, which description is inconjunction with the attached drawings wherein:

FIG. 1 is a top plan view of a laparotomy sheet embodying the invention;

FIG. 2 is an enlarged section taken along line 2-2 of FIG. 1 and inwhich the thickness of the several drape components is greatlyexaggerated for reasons of clarity;

FIG. 3 is a bottom plan view of the laparotomy sheet of FIG. 1; and

FIG. 4 is a top plan view of a split sheet embodying the invention.

While the invention will be described in connection with certainpreferred embodiments, it will be understood that it is not intended tolimit the invention to these particular embodiments. On the contrary, itis intended to cover all alternatives, modifications, and equivalents asmay be included within the spirit and scope of the invention.

Turning now to the drawings, the illustrative laparotomy sheet shown inFIG. 1 includes a base sheet comprising out layers of wadding and innerlayers of highly drafted fibers disposed angularly to each other. Aspaced-pattem of adhesive is disposed between each fiber layer and itsadjacent wadding layer with the fibers in each fiber layer partiallyembedded in and held by the adhesive of its adjacent adhesive layer andpartially embedded in and held by the adhesive in the other adhesivelayer where it extends between the fibers of its adjacent fiber layerand with a portion of the adhesive in both adhesive layers joined wherethe adhesive patterns are superimposed. This material is described inmore detail in copending Sokolowski et al. application Ser. No. 546,067filed Apr. 28, 1966, now U.S. Pat. No. 3,484,330, and assigned to theassignee of the present invention.

In keeping with the present invention, a sheet of fluid imperviousplastic film 11 is laminated to the top surface of the base sheet 10over the primary operative area of the sheet, which in the exemplaryembodiment is the fenestration area of the laparotomy sheet. Alaparotomy sheet is an elongated, generally rectangular sheet used tocover all but the operative field of a patient during abdominal surgery,and is typically about 8 to 10 feet in length and about 5 to 8 feet inwidth. A fenestration or aperture 13 is located generally in the centralregion of the sheet, and is typically about 12 inches long by about 4inches wide. The film 11 may be bonded to the fibrous base sheet 10 byany suitable means, such as by means of an adhesive or by extruding thefilm directly on the base sheet 10. The film 11 provides a fluidimpervious barrier on the top surface of the operative area of the sheet10, so'that any fluids which contact this area cannot strike through thesheet. It also prevents the transfer of bacteria through the sheet toinsure sterile conditions in the operative area. The film must becapable of remaining stable under the conditions encountered in theparticular treatment to which the laparotomy sheet is subjected torender it sterile, e.g., temperatures of about 270 F. for steamsterilization, or about 160 F. for sterilization by means of ethyleneoxide or the like.

Examples of suitable films are polyethylene, e.g., 2-mil antistaticpolyethylene film manufactured by Clopay Film Corp.; antistaticpolypropylene, e.g., Extrel II available from Extrudo Film Corp.;polyethylene methylacrylate co-polymer film manufactured by EdisonPlastics Company; and vinyl chloride films. The film should besubstantially free of pinholes, and thus must generally be at least 1.5mil thick, to provide the desired sterility barrier.

To provide a fluid absorbent outer surface on the drape, while at thesame time providing a high frictional coefficient, a sheet of fluidabsorbent flexible'plastic foam material 12 is laminated to the outersurface of the fluid impervious film 11. The foam material 12 may bebonded to the film 11 by any suitable means, such as by means of anadhesive, by fusing, or by extruding the film 11 directly on the foammaterial 12.

The absorbency of the absorbent open-cell foam l2 prevents excessivefluid runoff, and yet the absorbed fluids cannot strike through thedrape because of the intermediate layer of fluid impervious film 11. Therelatively high frictional coefficient of the foam material provides asubstantially nonslip surface which prevents the accidental dislodgmentof surgical instruments and the like. In addition, the foam 12 shouldhavea low glare, which may be achieved by using a colored foam. Examplesof suitable foams are 40 mil polyester polyurethane foam, available fromReeves Bros. or Tenneco Chemicals, Inc. having a density of 1.75lbs./ft. and polyether polyurethane foams. The foam thickness shouldgenerally be in the range of from about 25 mils to about mils, and theabsorbency of the foam sheet should be at least about percent and atleast about 3 gm. per 4 X 4 inches sample, preferably at least 575percent and at least 4.5 gm. per 4 X 4 inches sample. The foam sheetshould also have a frictional coefficient of at least about 20.

In order to prevent sparking due to the buildup of static electricalcharges on the drape, which can be hazardous with the potentiallyexplosive gases that are often present in the operating room, the foam12 should also be antistatic. It is not necessary for the intermediatefilm 11 to be antistatic unless the specific design of the drape is suchthat the film 11 is exposed in a certain area, e.g., around theoperative opening in the fenestration area of a laparotomy sheet.

In accordance with the present invention, a pair of elongated strips ofnormally tacky and pressure-sensitive adhesive are bonded to the basesheet substantially coextensive with one pair of opposed edges of thefenestration, the elongated strips of adhesive being continuously spacedapart from each other by the fenestration, and the other pair of opposededges of the fenestration being free of the adhesive to facilitaterepositioning of the drape on the patient. The exposed adhesive is usedto adhesively attach the drape to the patient both to prevent the drapefrom slipping on the patient and to hold the drape flat against thepatient to prevent instruments, sponges, sutures and fluids frominadvertently getting under the drape. Thus, in the illustrativelaparotomy sheet of FIGS. 1-3, a pair of elongated strips 20 and 21 ofnormally tacky and pressuresensitive adhesive are bonded to the basesheet the full length of the longer or longitudinal side edges 22 and23, respectively, defining a major portion of the fenestration l3, andthe width of the adhesive strips and 21 is such that they extend asubstantial distance away from the edges 22 and 23. The other pair ofopposed edges of the fenestration 13, namely the end edges 24 and 25,are free of adhesive, so that the elongated strips 20 and 21 arecontinuously spaced apart from each other by the fenestration 13.Consequently, the adhesive strips provided on the underside of thelaparotomy sheet extend substantially in only one direction, therebyfacilitating repositioning of the sheet after it has been placed on andsecured to the patient. More specifically, if it is desired toreposition the laparotomy sheet after it has been initially placed onthe patient, the sheet can be quickly removed from the patient by simplypulling it upwardly away from the patient in the longitudinal direction,i.e., there are no transverse adhesive attachments to impede the removaland re-positioning operations. After the sheet has been removed from thepatient, it can be readily moved longitudinally in either direction toaline the fenestration 13 with the desired operative area on thepatient.

Normally tacky and pressure-sensitive adhesives for use herewith may beany of the biologically acceptable pressuresensitive adhesivesavailable. Adhesives of this class are generally composed of afilm-forming elastomeric material, typically a natural or syntheticrubber, and some type of resin or other material to impart the desireddegree of tack, wetting power, and specific adhesion. Typical resinsinclude the rosin derivatives such as hydrogenated or dehydrogenatedrosin or their esters. Various fillers, plasticizers, sterilizingagents, or other modifiers may also be used. For further descriptions ofsuch adhesives, see Kirk-Othmer, Encyclopedia of Chemical Technology,Second Edition, Vol. 1, page 382 (Interscience I963).

To protect the adhesive-coated areas, peel strips 26 and 27 are employedto cover at least the adhesive strips 20 and 21, respectively. The peelstrips 26 and 27 are illustratively a plastic, heavy paper, or non-wovenfabric having a release coating to which the adhesive strips 20 and 21can be secured only lightly. Coatings suitable for this purpose includenatural or synthetic waxes, metal salts of fatty acids, polymericmaterials such as polyethylene or silicone polymers, etc. Releasecoatings are discussed in Kirk-Othmers Encyclopedia", Second Edition,Vol. 1, page 1 et seq.

As shown most clearly in FIGS. 2-4, the peel strips 26 and 27 preferablyextend slightly beyond the outboard longitudinal edges of the respectiveadhesive strips to facilitate removal of the peel strips when it isdesired to place the drape on the patient. Other types of peel strips,such as slit strips, may also be used to facilitate removal, but is hasbeen found that the extended liner shown in FIGS. 2-4 providessignificant advantages in facilitating removal, minimizing removal timeand preserving aseptic conditions.

One particularly preferred technique for applying the adhesive strips 20and 21 and the corresponding peel strips 26 and 27 to the laparotomysheet is to apply the adhesive and peel strip simultaneously inpre-laminated form. One especially suitable starting material for thistechnique is Minnesota Mining and Manufacturing Product No. 1522, whichcomprises a continuous strip of double-coated adhesive transfer tapeconsisting of polyethylene film coated on both sides with an acryliccopolymer adhesive. The tape is laminated to a continuous release stripor liner supplied in continuous release roll form. The tape thickness is6 mils, the liner thickness is 5 mils, and the tape demonstrates 30oz./in. adhesion to steel and has a moisture vapor transport rate of0.85 gm./l00 in./24 hours. A suitable tape width for laparotomy drapesis 2 inches, although the invention is not limited to this particularwidth.

When the transfer tape is cut in to appropriate lengths and applied to alaparotomy sheet, for example, the adhesive on one side of thepolyethylene film strip bonds the strip to the base sheet 11, while theadhesive on the other side is protected by the release strip untilremoval of the release strip at the time of application of the drape tothe patient. The use of this material provides an extremely efficientmanufacturing technique, and one which can be carried out at highproduction rates. Moreover, it has been found that surgical drapeshaving the aforementioned film-adhesive starting material appliedthereto can be subjected to conventional ethylene oxide sterilizationtechniques (the polyethylene film cannot be sterilized by autoclaving)without suffering degradation of the adhesive. Sterility tests conductedwith bacillus subtilis spore strips, laminated between the tape and thenonwoven fabric, or between the tape and its release strip, showed thatno growth occurred (incubation at 37 C. for 7 days) after the laminateswere subjected to a conventional ethylene oxide sterilization treatment.Furthermore, it has been found that the aforementioned transfer tapeprovides a stronger bond between the tape and the base sheet 11 than thebond between the tape and the patients skin, thereby furtherfacilitating repositioning of the drapes during a surgical operation.This tape also has good aging characteristics and is safe for contactwith human skin.

In an alternative embodiment of the invention illustrated in FIG. 4, thetwo adhesive strips 30 and 31 of normally tacky and pressure-sensitiveadhesive are bonded to opposite side edges of the elongated opening in aconventional split sheet 32. When the peel strips 33 and 34,respectively, are peeled off the adhesive strips 30 and 31, the exposedadhesive is used to adhesively attach the split sheet 32 to the patientboth to prevent the sheet from slipping on the patient and to hold thesheet flat against the patient to prevent instruments, sponges, suturesand the like resting on the foam top surface of the fenestration area ofthe sheet from inadvertently getting under the sheet. The adhesiveattachment of the sheet also prevents the sheet from hindering thesurgeon in the operative field. Since the adhesive strips 30 and 31 aredisposed on only one pair of opposed side edges of the opening, thesplit sheet 32 can be readily repositioned in the same manner describedabove for the laparotomy sheet, i.e., it can be detached from thepatient by pulling it upwardly away from the patient in a longitudinaldirection, and then moved to the desired position before beingreattached to the patient.

We claim as our invention:

1. An improved disposable surgical drape comprising the combination of afibrous base sheet having an opening, a fluid impervious plastic filmsecured to said base sheet over the primary operative area of said sheetand forming a fenestration area with an opening smaller than and withinsaid fenestration area, a sheet of fluid absorbent flexible open cellplastic foam material laminated to the top surface of said film in saidfenestration area and forming an opening said openings in said basesheet, plastic film and foam material being substantially coextensiveand forming a fenestration in said fenestration area, a coating ofnormally tacky and pressure sensitive adhesive applied to the undersurface of said base sheet substantially coextensive with opposite edgesof a major portion of said fenestration, and removable peel stripscovering said adhesive coating; said film, said foam, and said adhesiveall being stable at sterilizing temperatures to permit sterilization ofthe surgical drape, the combination of l) the fluid impervious plasticfilm and fluid absorbent foam on the drape top surface, and (2) theadhesive on the drape under surface, providing an absorbent reinforcedarea with a frictional top surface adjacent the fenestration forabsorbing fluid such as body fluid while preventing strike-through ofsuch fluid, for holding items such as instruments, sponges and suturessupported thereon from accidental dislodgement, and enabling the drapeto be attached to a patient both to prevent the drape from slipping onthe patient and to hold the drape flat against the patient adjacent thefenestration to prevent such items and fluids from inadvertently gettingunder the drape through the fenestration.

2. A drape according to claim 1 wherein said fenestration has straightopposite edges, and said coating of adhesive is applied to the drapeunder surface in the form of straight strips immediately adjacent saidstraight opposite edges of said fenestration.

3. A drape according to claim 2 wherein said straight adhesive stripslie parallel to and immediately adjacent said straight opposite edges ofthe fenestration, and the other edges of said fenestration are free ofadhesive.

4. A drape according to claim 1 wherein said foam is a colored foam toreduce glare.

5. An improved disposable surgical drape comprising the combination of afibrous base sheet having an opening, a fluid impervious plastic filmsecured to said base sheet, extending over the primary operative area ofsaid sheet and forming a fenestration area with a fenestration smallerthan and within said fenestration area, a sheet of fluid absorbentflexible open cell plastic foam material substantially coextensive withand laminated to the top surface of said film throughout saidfenestration area and forming an opening said foam having a frictionalcoefficient of at least about said openings in said base sheet, plasticfilm and foam material being substantially coextensive and forming afenestration in said fenestration area, a coating of normally tacky andpressure sensitive adhesive applied to the under surface of said basesheet substantially coextensive with opposite edges of saidfenestration, and removable peel strips covering said adhesive coating;said film, said foam, and said adhesive all being stable at temperaturesup to at least about 160 F to permit sterilization of the surgicaldrape, the combination of l) the fluid impervious plastic film andcoextensive fluid absorbent foam on the drape top surface and (2) theadhesive on the drape under surface, providing a top surface entirelyaround the fenestration for absorbing fluid such as body fluid, whilepreventing strikethrough of such fluid, providing a reinforcedfrictional top surface entirely around the fenestration where the drapeis subject to extreme stress to hold items such as instruments,

sponges and sutures supported thereon from accidental dislodgement, andenabling the drape to be attached to a patient both to prevent the drapefrom slipping on the patient and to hold the drape flat against thepatient adjacent the fenestration to prevent such items and fluids frominadvertently getting under the drape through the fenestration openmg.

6. An improved disposable surgical drape comprising the combination of areinforced porous fibrous base sheet forming a fenestration opening, afluid impervious plastic film secured to said base sheet over theprimary operative area of said sheet and forming a fenestration areawith a fenestration opening smaller than and within said fenestrationarea, a sheet of fluid absorbent flexible open cell plastic foammaterial laminated to the top surface of said film in said fenestrationarea and forming an opening, said openings in said base sheet, plasticfilm and foam material being substantially coextensive and forming afenestration in said fenestration area, a coating of normally tacky andpressure sensitive adhesive applied to the under surface of said basesheet substantially coextensive with opposite 1 edges of saidfenestration, and removable peel strips covering said adhesive coating;said film, said foam, and said adhesive all being stable at sterilizingtemperatures to permit sterilization of the surgical drape, thecombination of l) the fluid impervious plastic film and fluid absorbentfoam on the drape top surface and (2) the adhesive on the drape undersurface, providing a top surface adjacent the fenestration for absorbingfluid such as body fluid while preventing a strike-through of suchfluid, providing a further reinforcement and a frictional top surfaceadjacent the fenestration to hold items such as instruments, sponges andsutures supported thereon from accidental dislodgement, and enabling thedrape to be attached to a patient both to prevent the drape fromslipping on the patient and to hold the drape flat against the patientadjacent the fenestration to prevent such items and fluids frominadvertently getting under the drape through the fenestration.

1. An improved disposable surgical drape comprising the combination of afibrous base sheet having an opening, a fluid impervious plastic filmsecured to said base sheet over the primary operative area of said sheetand forming a fenestration area with an opening smaller than and withinsaid fenestration area, a sheet of fluid absorbent flexible open cellplastic foam material laminated to the top surface of said film in saidfenestration area and forming an opening said openings in said basesheet, plastic film and foam material being substantially coextensiveand forming a fenestration in said fenestration area, a coating ofnormally tacky and pressure sensitive adhesive applied to the undersurface of said base sheet substantially coextensive with opposite edgesof a major portion of said fenestration, and removable peel stripscovering said adhesive coating; said film, said foam, and said adhesiveall being stable at sterilizing temperatures to permit sterilization ofthe surgical drape, the combination of (1) the fluid impervious plasticfilm and fluid absorbent foam on the drape top surface, and (2) theadhesive on the drape under surface, providing an absorbent reinforcedarea with a frictional top surface adjacent the fenestration forabsorbing fluid such as body fluid while preventing strike-through ofsuch fluid, for holding items such as instruments, sponges and suturessupported thereon from accidental dislodgement, and enabling the drapeto be attached to a patient both to prevent the drape from slipping onthe patient and to hold the drape flat against the patient adjacent thefenestration to prevent such items and fluids from inadvertently gettingunder the drape through the fenestration.
 2. A drape according to claim1 wherein said fenestration has straight opposite edges, and saidcoating of adhesive is applied to the drape under surface in the form ofstraight strips immediately adjacent said straight opposite edges ofsaid fenestration.
 3. A drape according to claim 2 wherein said straightadhesive strips lie parallel to and immediately adjacent said straightopposite edges of the fenestration, and the other edges of saidfenestration are free of adhesive.
 4. A drape according to claim 1wherein said foam is a colored foam to reduce glare.
 5. An improveddisposable surgical drape comprising the combination of a fibrous basesheet having an opening, a fluid impervious plastic film secured to saidbase sheet, extending over the primary operative area of said sheet andforming a fenestration area with a fenestration smaller than and withinsaid fenestration area, a sheet of fluid absorbent flexible open cellplastic foam material substantially coextensive with and laminated tothe top surface of said film throughout said fenestration area andforming an opening said foam having a frictional coefficient of at leastabout 20*, said openings in said base sheet, plastic film and foammaterial being substantially coextensive and forming a fenestration insaid fenestration area, a coating of normally tacky and pressuresensitive adhesive applied to the under surface of said base sheetsubstantially coextensive with opposite edges of said fenestration, andremovable peel strips covering said adhesive coating; said film, saidfoam, and said adhesive all being stable at temperatures up to at leastabout 160* F., to permit sterilization of the surgical drape, thecombination of (1) the fluid impervious plastic film and coextensivefluid absorbent foam on the drape top surface and (2) the adhesive onthe drape under surface, providing a top surface entirely around thefenestration for absorbing fluid such as body fluid, while preventingstrike-through of such fluid, providing a reinforced frictional topsurface entirely around the fenestration where the drape is subject toextreme stress to hold items such as instruments, sponges and suturessupported thereon from accidental dislodgement, and enabling the drapeto be attached to a patient both to prevent the drape from slipping onthe patient and to hold the drape flat against the patient adjacent thefenestration to prevent such items and fluids from inadvertently gettingunder the drape through the fenestration opening.
 6. An improveddisposable surgical drape comprising the combination of a reinforcedporous fibrous base sheet forming a fenestration opening, a fluidimpervious plastic film secured to said base sheet over the primaryoperative area of said sheet and forming a fenestration area with afenestration opening smaller than and within said fenestration area, asheet of fluid absorbent flexible open cell plastic foam materiallaminated to the top surface of said film in said fenestration area andforming an opening, said openings in said base sheet, plastic film andfoam material being substantially coextensive and forming a fenestrationin said fenestration area, a coating of normally tacky and pressuresensitive adhesive applied to the under surface of said base sheetsubstantially coextensive with opposite edges of said fenestration, andremovable peel strips covering said adhesive coating; said film, saidfoam, and said adhesive all being stable at sterilizing temperatures topermit sterilization of the surgical drape, the combination of (1) thefluid impervious plastic film and fluid absorbent foam on the drape topsurface and (2) the adhesive on the drape under surface, providing a topsurface adjacent the fenestration for absorbing fluid such as body fluidwhile preventing a strike-through of such fluid, providing a furtherreinforcement and a frictional top surface adjacent the fenestration tohold items such as instruments, sponges and sutures supported thereonfrom accidental dislodgement, and enabling the drape to be attached to apatient both to prevent the drape from slipping on the patient and tohold the drape flat against the patient adjacent the fenestration toprevent such items and fluids from inadvertently getting under the drapethrough the fenestration.